Clinical trials: Kidney Insufficiency
Chronic Kidney Disease
Novel Endovascular Access Trial (NEAT)
The objective of this study is to evaluate the safety and efficacy of the FLEX System when used to create an arteriovenous fistula (AVF or AV fistula) percutaneously in patients with Chronic Kidney Disease (CKD) who require…
- Trial name
- NEAT (NCT02036671)
- Testing
- The FLEX System will be used to percutaneously create a fistula in CKD patients who require hemodialysis vascular access
- Where
- 9 sites in Australia, Canada and 1 more
- Volunteers
- 80 people
- Sponsor
- C. R. Bard
Chronic Kidney Disease Requiring Chronic Dialysis, Hyperphosphatemia
PA21 Safety and Efficacy in Adult Chinese Subjects
This study evaluates the efficacy of PA21 in comparison with sevelamer carbonate (Renvela®) in lowering and maintaining serum phosphorus in adult Chinese subjects with CKD on dialysis after 12 weeks of treatment.
- Trial name
- NCT03644264
- Testing
- PA21, sevelamer carbonate
- Where
- China
- Volunteers
- 286 people
- Sponsor
- Vifor Fresenius Medical Care Renal Pharma
Acute Kidney Injury, Acute Kidney Injury Due to Sepsis
QUELIMMUNE (SCD-PED) PediAtric SurVeillance REgistry
QUELIMMUNE is FDA-approved under an HDE for the treatment of pediatric patients (weight ≥10kg and age ≤22 years) with AKI due to sepsis or a septic condition on antibiotic therapy and requiring RRT.
- Trial name
- SAVE (NCT06517810)
- Testing
- QUELIMMUNE (SCD-PED)
- Where
- 15 sites in United States
- Volunteers
- 50 people
- Sponsor
- SeaStar Medical
Non-valvular Atrial Fibrillation
Safety and Pharmacokinetics Study of DU-176b Administered to Non-valvular Atrial Fibrillation With Severe Renal Impairment
To assess the safety and pharmacokinetics of DU-176b administered to non-valvular atrial fibrillation patients with severe renal impairment, compared with DU-176b administered to non-valvular atrial fibrillation (NVAF) patients…
- Trial name
- NCT01857622
- Testing
- DU-176b 15mg, DU-176b 30mg, DU-176b 60mg
- Where
- Japan
- Volunteers
- 93 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Stage 5 Chronic Kidney Disease (CKD), Secondary Hyperparathyroidism (SHPT)
Four Week, Pharmacodynamic/Pharmacokinetic, Efficacy, and Safety Study of Lunacalcipol (CTA018)
Open-label, pharmacodynamic, safety, pharmacokinetic and efficacy study of Lunacalcipol Injection.
- Conditions
- Stage 5 Chronic Kidney Disease (CKD), Secondary Hyperparathyroidism (SHPT), Hemodialysis (HD)
- Trial name
- 2007 (NCT01453634)
- Testing
- Lunacalcipol 180, Lunicalcipol 270
- Sponsor
- OPKO Health, Inc.
Healthy Subjects, Pharmacokinetics of ASP8232
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of ASP8232 in Subjects With Renal Impairment and in Type 2 Diabetes Mellitus Subjects With Chronic Kidney Disease
This study consists of two parts. Part 1 evaluates the effect of renal impairment on the PK and PD of a single dose of ASP8232. In addition, the safety and tolerability will be assessed.
- Conditions
- Healthy Subjects, Pharmacokinetics of ASP8232, Pharmacodynamics of ASP8232, Chronic Kidney Disease (CKD)
- Trial name
- NCT02218099
- Testing
- ASP8232
- Where
- 3 sites in Bulgaria, Moldova and 1 more
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Europe B.V.
Infection, Human Immunodeficiency Virus, HIV Infections
Pharmacokinetics Study of GSK1265744 in Subjects With Severe Renal Impairment
GSK1265744 (744) is an integrase strand transfer inhibitor (INSTI) currently in development for both the treatment and prevention of human immunodeficiency virus (HIV) infection.
- Trial name
- NCT02354937
- Testing
- GSK1265744 30 mg
- Where
- 2 sites in United States
- Volunteers
- 16 people
- Sponsor
- ViiV Healthcare
Chronic Hepatitis B Infection
Single Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Pevifoscorvir Sodium (ALG-000184) in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function
This is a Phase 1 non-randomized, open-label, single-dose study of pevifoscorvir sodium (also known as ALG-000184) in participants with severe renal impairment (Part 1), in participants with mild or moderate renal impairment…
- Trial name
- NCT07342881
- Testing
- Pevifoscorvir Sodium (ALG-000184)
- Where
- 2 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Aligos Therapeutics
Hypertrophic Cardiomyopathy
Safety and Pharmacokinetics Study of HRS-1893 Tablets in Healthy Subjects and Those With Impaired Kidney Function
The primary objective is to evaluate pharmacokinetics of HRS-1893 tablets in subjects with impaired kidney function in comparison with healthy subjects, to develop dose recommendations for patients with renal impairment.
- Trial name
- NCT06775834
- Testing
- HRS-1893
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.
Obesity & Overweight
A Pharmacokinetic Study of VCT220 With Moderate Renal Impairment Patients
This Phase 1 study is designed to evaluate the pharmacokinetics and safety of a single oral dose of VCT220 (other name: CX11) in subjects with moderate renal impairment compared with age-, sex-, and body mass index (BMI)-matched…
- Trial name
- NCT07347808
- Testing
- VCT220
- Where
- China
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Vincentage Pharma Co., Ltd
Chronic Kidney Disease
In Vivo Evaluation of the Nipro Elisio™ Dialyzer
The purpose of this study is to compare the efficacy and biocompatibility of the Nipro Elisio 210H dialyzer between two dialysis modalities, conventional hemodialysis and on line hemodiafiltration.
- Trial name
- NCT01653808
- Testing
- Elisio-210H, conventional hemodialysis, on line hemodiafiltration
- Where
- France
- Volunteers
- 20 people
- Sponsor
- Nipro Europe N.V.
Acute Myeloid Leukemia, Myelodysplastic Syndromes
Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Renal Impairment
This is a Phase 1b, multicenter, open-label, PK, and safety study of multiple oral doses of oral decitabine and cedazuridine (formerly known as ASTX727) as a fixed-dose combination of decitabine 35 milligrams (mg) and…
- Trial name
- NCT04953897
- Testing
- ASTX727
- Where
- 21 sites in United States, Armenia and 6 more
- Volunteers
- 18 people
- Sponsor
- Taiho Oncology, Inc.
Kidney Failure, Graft vs Host Disease
Study Comparing Cyclosporine Dose Reduction vs. Cyclosporine Elimination in Kidney Transplant Recipients Taking Sirolimus
Compare kidney function as measured by calculated creatinine clearance (using the method by Nankivell)1 at 12 months after transplantation in subjects receiving induction therapy with cyclosporine microemulsion (CsA) and Rapamune…
- Trial name
- NCT00195468
- Testing
- CYCLOSPORINE
- Where
- 13 sites in Brazil, Mexico
- Volunteers
- 280 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
End-Stage Renal Disease
Cook Enforcer Post-Market Study
The purpose of this study is to evaluate the performance of the Cook Advance® Enforcer™ 35 Focal-Force PTA Balloon Catheter (or Enforcer balloon) in treating narrowed blood vessels compared to treatment with a conventional…
- Trial name
- NCT03552289
- Testing
- Cook Advance® Enforcer 35 Focal-Force Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter, Conventional angioplasty balloon catheters
- Where
- 5 sites in United States
- Volunteers
- 211 people
- Sponsor
- Cook Research Incorporated
Chronic Kidney Failure, Acute Kidney Failure
Theranova Randomized, Controlled, Trial (RCT) in China
Traditional hemodialysis (HD) therapy is very effective in clearing urea and smaller middle molecules, but is limited in clearing larger middle molecules.
- Trial name
- ROCKet (NCT05309291)
- Testing
- Theranova 400 Dialyzer, FX 800 Dialyzer
- Where
- 10 sites in China
- Volunteers
- 323 people
- Sponsor
- Vantive Health LLC
Calciphylaxis
SEAPORT 1: Study of INZ-701 in Adults With Hemodialysis-Dependent End-Stage Kidney Disease
This Phase 1, open-label, multicenter study evaluated the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of INZ-701 in adults with hemodialysis-dependent end-stage kidney disease (ESKD) and low plasma inorganic…
- Trial name
- SEAPORT 1 (NCT06283589)
- Testing
- INZ-701
- Where
- 2 sites in United States
- Volunteers
- 11 people
- Sponsor
- Inozyme Pharma
Dialysis, Chronic Renal Failure
A Study to Demonstrate the Safety and Effectiveness of the NIKKISO DBB-EXA ES Hemodialysis Delivery System
The study objective is to verify the safety and effectiveness of the DBB-EXA ES Hemodialysis Delivery System to consistently deliver dialysate of the appropriate quality for infusion.
- Trial name
- HEMO (NCT04655989)
- Testing
- DBB-EXA ES Hemodialysis System
- Where
- 2 sites in United States
- Volunteers
- 31 people
- Sponsor
- Nikkiso America, Inc.
Rhabdomyolysis, Renal Failure
Myoglobin Removal by High Cut-off CVVHD
A high cut-off dialyzer (septeX) is tested for the removal of myoglobin which is not efficiently removed by standard high flux dialysis membranes.
- Trial name
- HicoRhabdo (NCT01467180)
- Testing
- septeX, HF CVVH
- Where
- Germany
- Volunteers
- 16 people
- Sponsor
- Vantive Health LLC
CKD Anemia
A Study of Roxadustat for the Treatment of Anemia in Participants With Chronic Kidney Disease and Not Receiving Dialysis
The purpose of this study is to determine whether roxadustat is safe and effective in the treatment of anemia in participants with chronic kidney disease and not on dialysis.
- Trial name
- NCT01750190
- Testing
- Roxadustat
- Where
- 145 sites in United States, Argentina and 14 more
- Volunteers
- 922 people
- Sponsor
- Kyntra Bio
Renal Insufficiency, Kidney Diseases
Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of INCB054707 in Participants With Normal and Impaired Renal Function and Participants on Hemodialysis
This is a multi-center, open-label, parallel-group study to evaluate oral doses of INCB054707 in participants with varying levels of renal function or impairment.
- Trial name
- NCT05624723
- Testing
- INCB054707
- Where
- 2 sites in United States, Germany
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Incyte Corporation
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